Improving Supportive Care For Patients With Thoracic Malignancies

NCT03216109 | Completed

• 1 other identifier: PAT0001ARG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use a proactive approach to improve symptom management of patients with thoracic malignancies and ensure receipt of evidence-based cancer care delivery. In this pilot study, the investigators propose to evaluate the feasibility of using outbound, proactive telephone symptom assessment strategies and ensuring evidence-based care receipt and measure the efficacy of this approach on patient satisfaction with their care, patient activation, quality of life and use of healthcare resources.

Conditions

Lung Cancer; Quality of Life; Supportive Care

Keywords

Supportive Care; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Symptom documentation

  Defined as 75% documentation of symptoms for patients in the intervention arm

  6 months after patient enrollment

Secondary Outcomes (14)

• Emergency Department Visit (Chart Review)

  9 months after patient enrollment

• Hospitalizations (Chart Review)

  9 months after patient enrollment

• Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey

  Change in Quality of Life from baseline to month 3

• Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey

  Change in Quality of Life from baseline to month 6

• Change in Quality of Life using the Functional Assessment of Cancer Therapy - Lung survey

  Change in Quality of Life from baseline to month 9

Study Arms (2)

Weekly telephone symptom assessment

EXPERIMENTAL

Each patient who is enrolled in the intervention will receive a weekly phone call from the Research Assistant for a total of 9 months to assess symptoms using the Edmonton Symptom Assessment Scale. Results of the symptom assessments will be provided to the clinic staff (RN and MD) for review each week. Symptom assessments will be documented into an encrypted, HIPAA compliant digital platform which provides longitudinal symptom data management and also provides symptom assessment tools for the clinical team in their intervention strategies. In addition, patients will complete symptom and quality of life surveys at 0, 3, 6 and 9 months.

Behavioral: Weekly telephone symptom assessment

Control Arm

NO INTERVENTION

Patients randomized to usual clinical care will receive standard of care for thoracic malignancies as provided by the VA Palo Alto Health Care System. Patients will complete outcome surveys at 0, 3, 6, and 9 months.

Interventions

Weekly telephone symptom assessment BEHAVIORAL

Each patient who is enrolled in the intervention will receive a weekly phone call from the Research Assistant for a total of 9 months to assess symptoms using the Edmonton Symptom Assessment Scale. Results of the symptom assessments will be provided to the clinic staff (RN and MD) for review each week. Care plans will be generated using an electronic management platform

Weekly telephone symptom assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with lung cancer treated at VA Palo Alto. This includes all newly diagnosed patients and those under follow-up care.

You may not qualify if:

• Patients who do not anticipate receiving oncology care at the VA Palo Alto Health Care System.
• Patients who are unable to consent.

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Carevive Systems, Inc.: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• Banks LC, Kapphahn K, Das M, Patel MI. Randomized Trial of a Volunteer-Led Symptom Assessment Intervention on Documentation, Patient-Reported Outcomes, and Health Care Use Among Veterans With Lung Cancer. JCO Oncol Pract. 2024 Mar;20(3):419-428. doi: 10.1200/OP.23.00557. Epub 2024 Jan 11.

  PMID: 38207246 DERIVED

• Patel MI, Banks L, Das M. Improving supportive care for patients with Thoracic Malignancies - A randomized controlled trial. Contemp Clin Trials Commun. 2022 May 27;28:100929. doi: 10.1016/j.conctc.2022.100929. eCollection 2022 Aug.

  PMID: 35669484 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Manali I Patel, MD

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Staff Oncologist VAPAHCS

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 13, 2017
• Study Start: August 20, 2017
• Primary Completion: June 28, 2023
• Study Completion: December 31, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)